California Legislature—2015–16 Regular Session

Assembly BillNo. 1977


Introduced by Assembly Members Wood and Waldron

February 16, 2016


An act to add Section 1367.217 to the Health and Safety Code, and to add Section 10123.203 to the Insurance Code, relating to health coverage.

LEGISLATIVE COUNSEL’S DIGEST

AB 1977, as introduced, Wood. Health coverage: abuse-deterrent opioid analgesics.

Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of that act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. These provisions require specified services and drugs to be covered by the various health care service plans and health insurers.

This bill would require an individual or group health care service plan or disability insurance policy issued, amended, or renewed after January 1, to provide coverage on its formulary, drug list, or other lists of similar construct for at least one abuse-deterrent opioid analgesic drug product per opioid analgesic active ingredient. The bill would require that the total amount of copayments and coinsurance an enrollee or insured is required to pay for brand name abuse-deterrent opioid analgesic drug products covered pursuant to the bill not exceed the lowest cost-sharing level applied to brand name or generic prescription drugs covered under the applicable health care service plan or insurer, as specified. The bill would prohibit a health care service plan or insurer from requiring an enrollee or an insured to first use a non-abuse-deterrent opioid analgesic drug product before providing coverage for an abuse-deterrent opioid analgesic drug product, subject to uniformly applied utilization review requirements described in the bill.

Because a willful violation of these requirements with respect to health care service plans would be a crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

The people of the State of California do enact as follows:

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SECTION 1.  

The Legislature finds and declares as follows:

2(a) Abuse and misuse of opioids is a serious problem that affects
3the health, social, and economic welfare of the state.

4(b) After alcohol, prescription drugs are the most commonly
5abused substances by Americans over 12 years of age.

6(c) Almost 2,000,000 people in the United States suffer from
7substance use disorders related to prescription opioid pain relievers.

8(d) Nonmedical use of prescription opioid pain relievers can be
9particularly dangerous when the products are manipulated for
10snorting, injection, or combination with other drugs.

11(e) Deaths involving prescription opioid pain relievers represent
12the largest proportion of drug overdose deaths, greater than the
13number of overdose deaths involving heroin or cocaine.

14(f) The number of unintentional overdose deaths involving
15prescription opioid pain relievers has more than quadrupled since
161999.

17

SEC. 2.  

Section 1367.217 is added to the Health and Safety
18Code
, to read:

19

1367.217.  

(a) Notwithstanding any other law, an individual
20or group health care service plan issued, amended, or renewed on
21or after January 1, that provides coverage for an opioid analgesic
22drug product shall comply with all of the following:

P3    1(1) The plan shall provide coverage on its formulary, drug list,
2or other lists of similar construct for at least one abuse-deterrent
3opioid analgesic drug product per opioid analgesic active
4ingredient.

5(2) Notwithstanding any deductible, the total amount of
6copayments and coinsurance an enrollee is required to pay for
7brand name abuse-deterrent opioid analgesic drug products covered
8pursuant to this section shall not exceed the lowest cost-sharing
9 level applied to brand name prescription drugs covered under the
10applicable health care service plan.

11(3) Notwithstanding any deductible, the total amount of
12copayments and coinsurance an enrollee is required to pay for
13generic abuse-deterrent opioid analgesic drug products covered
14pursuant to this section shall not exceed the lowest cost-sharing
15level applied to generic prescription drugs covered under the
16applicable health care service plan.

17(4) The plan shall not require an enrollee to first use a
18non-abuse-deterrent opioid analgesic drug product before providing
19coverage for an abuse-deterrent opioid analgesic drug product.
20This paragraph shall not be construed to prevent a health care
21service plan from applying utilization review requirements,
22including prior authorization, to abuse-deterrent opioid analgesic
23drug products, provided that those requirements are applied to all
24 opioid analgesic drug products with the same type of drug release,
25immediate or extended.

26(b) The following definitions shall apply for purposes of this
27section:

28(1) “Abuse-deterrent opioid analgesic drug product” means a
29brand or generic opioid analgesic drug product approved by the
30federal Food and Drug Administration (FDA) with
31abuse-deterrence labeling claims indicating its abuse-deterrent
32properties are expected to deter or reduce its abuse.

33(2) “Cost sharing” means any coverage limit, copayment,
34coinsurance, deductible, or other out-of-pocket expense
35requirement.

36(3) “Opioid analgesic drug product” means a drug product that
37contains an opioid agonist and that is indicated by the FDA for the
38treatment of pain, whether in an immediate release or extended
39release formulation and whether or not the drug product contains
40any other drug substance.

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SEC. 3.  

Section 10123.203 is added to the Insurance Code, to
2read:

3

10123.203.  

(a) Notwithstanding any other law, an insurer
4issuing, amending, or renewing a policy of individual or group
5disability insurance on or after January 1, that provides coverage
6for an opioid analgesic drug product shall comply with all of the
7following:

8(1) The insurer shall provide coverage on its formulary, drug
9list, or other lists of similar construct for at least one
10abuse-deterrent opioid analgesic drug product per opioid analgesic
11active ingredient.

12(2) Notwithstanding any deductible, the total amount of
13copayments and coinsurance an insured is required to pay for brand
14name abuse-deterrent opioid analgesic drug products covered
15pursuant to this section shall not exceed the lowest cost-sharing
16level applied to brand name prescription drugs covered under the
17applicable policy.

18(3) Notwithstanding any deductible, the total amount of
19copayments and coinsurance an insured is required to pay for
20generic abuse-deterrent opioid analgesic drug products covered
21pursuant to this section shall not exceed the lowest cost-sharing
22level applied to generic prescription drugs covered under the
23applicable policy.

24(4) The insurer shall not require an insured to first use a
25non-abuse-deterrent opioid analgesic drug product before providing
26coverage for an abuse-deterrent opioid analgesic drug product.
27This paragraph shall not be construed to prevent an insurer from
28applying utilization review requirements, including prior
29authorization, to abuse-deterrent opioid analgesic drug products,
30provided that those requirements are applied to all opioid analgesic
31drug products with the same type of drug release, immediate or
32extended.

33(b) The following definitions shall apply for purposes of this
34section:

35(1) “Abuse-deterrent opioid analgesic drug product” means a
36brand or generic opioid analgesic drug product approved by the
37federal Food and Drug Administration (FDA) with
38abuse-deterrence labeling claims indicating its abuse-deterrent
39properties are expected to deter or reduce its abuse.

P5    1(2) “Cost sharing” means any coverage limit, copayment,
2coinsurance, deductible, or other out-of-pocket expense
3requirement.

4(3) “Opioid analgesic drug product” means a drug product that
5contains an opioid agonist and that is indicated by the FDA for the
6treatment of pain, whether in an immediate release or extended
7release formulation and whether or not the drug product contains
8any other drug substance.

9

SEC. 4.  

No reimbursement is required by this act pursuant to
10Section 6 of Article XIII B of the California Constitution because
11the only costs that may be incurred by a local agency or school
12district will be incurred because this act creates a new crime or
13infraction, eliminates a crime or infraction, or changes the penalty
14for a crime or infraction, within the meaning of Section 17556 of
15the Government Code, or changes the definition of a crime within
16the meaning of Section 6 of Article XIII B of the California
17Constitution.



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